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Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease (PAD)

20 de diciembre de 2021 actualizado por: Elizabeth Anne Jackson, University of Alabama at Birmingham
Peripheral arterial disease (PAD) is a significant vascular condition affecting millions of adults. Exercise such as walking is highly effective for reducing PAD symptoms such as claudication (pain with walking) and improving physical function. The trial examines the efficacy of a internet-delivered walking program for patients with PAD. Comparator groups including telephone counselling, the combination of internet-delivered walking program + telephone counseling, or usual care. The primary outcome of interest is maximal walking distance.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

With the aging of the American population, the numbers of adults with peripheral arterial disease (PAD) will increase significantly over the next several decades. Patients with PAD are at increased risk for morbidity and mortality including both cardiovascular and all-cause mortality. While regular physical activity reduces risk for vascular events and is recommended for treatment of PAD patients, few patients meet recommended goals. Exercise programs which increase long-term adherence to walking can be an important contribution to PAD treatment. Our Internet-based intervention, builds on a walking enhancement program developed by members of our team and is shown to improve adherence among patients with vascular disease such as coronary artery disease (CAD). Using a randomized, controlled trial study design, we propose to test an automated Internet-based walking program to improve long-term adherence to walking while increasing walking distance, and health-related quality of life, among patients with PAD. Participants will be randomized to 1 of four study groups: 1) weekly telephone counseling, 2) an Internet-based walking program, 3) a combination of telephone counseling and Internet-based walking program, or 4) a usual care group. The Internet-based walking program has been shown to increase both adherence to walking and overall walking duration in populations with chronic complex conditions such as CAD and diabetes. There is a strong need to develop interventions, easily generalizable to a real-world population, to improve the reach of lifestyle interventions which result in improved physical function and adherence to regular exercise among complex medical patients. Patients such as those with PAD (a CAD risk equivalent) stand to benefit the most from such programs.

Tipo de estudio

Intervencionista

Inscripción (Actual)

172

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama Birmingham
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • University of Michigan

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Age ≥ 40

Diagnosis of PAD due to atherosclerosis, documented by 1 or more of the following:

  • documented ankle brachial index (ABI) ≤ 0.9 in at least one leg
  • toe brachial index ≤ .70 for participants with an ABI > 1.3
  • documented arterial disease by MRI, CT or angiogram Ability to walk at least 150 feet without the assistance of a cane or walker. Are sedentary (defined as < 150 minutes per week of physical activity). Able to obtain medical clearance from a primary care provider, cardiologist, vascular specialist, endocrinologist, nurse practitioner, or physician assistant.

Competent to give informed consent. Have regular access to a computer with an Internet connection that allows software downloading.

Be a regular email user (check email at least once a week).

Exclusion Criteria:

PAD due to non-atherosclerotic causes such as trauma, entrapment syndromes or congenital anomalies.

No primary provider, or cardiologist or vascular provider Life expectancy of under 1-year Co-morbidities which limit physical activity to a severe degree (defined as the inability to walk a grocery store aisle unassisted) Signs of critical limb ischemia and/or planned peripheral revascularization in the next 12-months

A diagnoses of any of the following cardiovascular events in the past 3 months:

  • stroke/transient ischemic attack
  • myocardial infarction
  • unstable angina
  • percutaneous coronary intervention
  • coronary bypass graft surgery A diagnoses of any of the following cardiovascular conditions
  • severe valve disease untreated
  • complex arrhythmia untreated
  • New York Heart Association class III-IV heart failure Current substance abuse, or significant psychiatric disorder, or dementia which limits the participant's ability to follow the study protocol Pregnancy Non-English speaking

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Telephone Counseling
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs
Conductual: Telephone counseling
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Experimental: Internet-based walking program
Weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
Conductual: Internet-based walking program
Four-month Internet-based walking program consisting of weekly step count goals
Experimental: Telephone counseling and Internet-based walking program
Weekly telephone calls to assess compliance to exercise prescription and discuss various topics related to adoption and adherence to walking programs plus weekly automated goals are delivered via email to subject; goals are based on previous week's step count accumulation.
Conductual: Telephone counseling
4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
Conductual: Internet-based walking program
Four-month Internet-based walking program consisting of weekly step count goals
Sin intervención: Usual Care
Subjects will continue with their health care as usual

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in maximal walking distance
Periodo de tiempo: Baseline to 4 months
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Baseline to 4 months
Change in PAD-specific health-related quality of life
Periodo de tiempo: Baseline to 4 months
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Baseline to 4 months
Change in general health-related quality of life
Periodo de tiempo: Baseline to 4 months
measured using the EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable. The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
Baseline to 4 months
Change in global health-related quality of life
Periodo de tiempo: Baseline to 4 months
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric. A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
Baseline to 4 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in pain-free walking distance
Periodo de tiempo: Baseline to 4 months
measured using the Gardner-Skinner protocol treadmill test, time to onset of claudication
Baseline to 4 months
Change in maximal walking distance
Periodo de tiempo: Baseline to 12 months
measured using the Gardner-Skinner protocol treadmill test, noting time to moderate claudication
Baseline to 12 months
Change in PAD-specific health-related quality of life
Periodo de tiempo: Baseline to 12 months
measured using disease specific Peripheral Artery Questionnaire (PAQ) which uses scale scores of 0 to 100, with high numbers indicating better outcomes.
Baseline to 12 months
Change in general health-related quality of life
Periodo de tiempo: Baseline to 12 months
measured using EuroQol 5 Dimension Scale (EQ-5D) which is comprised of a descriptive system questionnaire containing 5 questions and a visual analogue scale ranging from 0 to 100 with 0 being worse health state imaginable and 100 being best health state imaginable. The descriptive system questionnaire is scored by assigning a 1-digit number to the participant's answer choice for each of the 5 questions, then combining each into a 5-digit number indicating their health state.
Baseline to 12 months
Change in global health-related quality of life
Periodo de tiempo: Baseline to 12 months
measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Questionnaire that includes questions from physical, mental, and social health domains and is scored using a T-score metric. A higher score equals more of a concept being measured which can indicate better or worse outcomes depending on the concept being measured.
Baseline to 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Alabama at Birmingham

Investigadores

  • Investigador principal: Elizabeth A. Jackson, MD MPH FACC, University of Alabama at Birmingahm

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2014

Finalización primaria (Actual)

1 de diciembre de 2021

Finalización del estudio (Actual)

1 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

5 de diciembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

20 de diciembre de 2013

Publicado por primera vez (Estimar)

27 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de diciembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

20 de diciembre de 2021

Última verificación

1 de diciembre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCT02022423

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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